SCHEDULES

Prospective

SCHEDULE 2U.K.Medical devices: civil sanctions

PART 1 U.K.Monetary penalties

Notices, representations and appeals etcU.K.

2(1)Where the Secretary of State proposes to impose a monetary penalty on a person, the Secretary of State must serve on the person a notice of what is proposed.U.K.

(2)A notice under sub-paragraph (1) must offer the person the opportunity to avoid liability in relation to a monetary penalty by payment of a sum specified in the notice (which must be less than or equal to the amount of the penalty).

(3)The person may make written representations and objections to the Secretary of State in relation to the proposed imposition of the monetary penalty.

(4)After the end of the period for making such representations and objections (see paragraph 3(2)) the Secretary of State must decide whether to serve on the person a notice imposing the monetary penalty.

(5)The Secretary of State may not impose a monetary penalty on a person if the Secretary of State is no longer satisfied as mentioned in paragraph 1(1).

(6)A person on whom a monetary penalty is imposed may appeal against the decision to impose the penalty on the ground—

(a)that the decision was based on an error of fact,

(b)that the decision was wrong in law,

(c)that the amount of the penalty is unreasonable, or

(d)that the decision is unfair, unreasonable or wrong for any other reason.

(7)An appeal under sub-paragraph (6) is to the First-tier Tribunal.

(8)Where an appeal is on the ground that the appellant did not commit an offence as mentioned in paragraph 1(1), the Tribunal must allow the appeal unless satisfied beyond reasonable doubt that the appellant committed the offence in question, according to the same burden of proof as would apply if the Secretary of State were seeking to prove the matter in a criminal prosecution.